Recall: D-0802-2018

Class II - Potentially Harmful

Class IIClassification

2018-04-19Initiated

TerminatedStatus

Sun Pharmaceutical Industries,Firm

Product

Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-count bottle, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St., Philadelphia, PA 19124, Dist, by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 53489-146-05

Reason

Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because a foreign matter identified as polyethylene was detected in two (2) tablets.

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA. If you take this product, talk to your pharmacist or doctor before stopping it.